Zosano Pharma
Zosano Pharma Corp (Form: 10-Q, Received: 05/09/2017 17:16:15)
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2017

or

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission File Number 001-36570

ZOSANO PHARMA CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware   45-4488360
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)

34790 Ardentech Court

Fremont, CA 94555

(Address of principal executive offices) (Zip Code)

(510) 745-1200

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes       No  

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes       No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer      Accelerated filer  
Non-accelerated filer     (Do not check if a smaller reporting company)    Smaller reporting company          
Emerging growth company           

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes       No  

As of May 4, 2017, the registrant had a total of 39,200,097 shares of its common stock, $0.0001 par value per share, outstanding.

 

 

 


Table of Contents

Zosano Pharma Corporation

Quarterly Report on Form 10-Q

INDEX

 

             Page        

PART I. FINANCIAL INFORMATION

   3

Item 1.

  Financial Statements    3
  Condensed Consolidated Balance Sheets    3
  Condensed Consolidated Statements of Operations and Comprehensive Loss    4
  Condensed Consolidated Statements of Cash Flows    5
  Notes to Condensed Consolidated Financial Statements    6

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   14

Item 3.

  Quantitative and Qualitative Disclosures About Market Risk    19
    

Item 4.

  Controls and Procedures    19

PART II. OTHER INFORMATION

   21

Item 1.

  Legal Proceedings    21

Item 1A

  Risk Factors    21
    

Item 2.

  Unregistered Sales of Equity Securities and Use of Proceeds    21

Item 3.

  Defaults Upon Senior Securities    21

Item 4.

  Mine Safety Disclosures    21

Item 5.

  Other Information    21

Item 6.

  Exhibits    21

SIGNATURES

   22

 

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PART I.    FINANCIAL INFORMATION

Item 1.    Financial Statements

ZOSANO PHARMA CORPORATION AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except par value and share amounts)

 

           March 31,      
2017
         December 31,    
2016
 
    

 

(unaudited)

        

 

A S S E T S

 

Current assets:

     

 

Cash and cash equivalents

     $ 37,341          $ 15,003    

 

Prepaid expenses and other current assets

     762          273    
  

 

 

    

 

 

 

 

Total current assets

     38,103          15,276    

 

Restricted cash

     35          35    

 

Property and equipment, net

     4,904          5,455    

 

Other long-term assets

     140          140    
  

 

 

    

 

 

 

 

Total assets

     $ 43,182          $ 20,906    
  

 

 

    

 

 

 
     
L I A B I L I T I E S  A N D  S T O C K H O L D E R S’  E Q U I T Y  

 

Current liabilities:

     

 

Accounts payable

     $ 907          $ 1,445    

 

Accrued compensation

     1,419          1,377    

 

Secured promissory note (including accrued interest), net of issuance costs, current portion

     6,106          5,992    

 

Other accrued liabilities

     1,126          1,005    
  

 

 

    

 

 

 

 

Total current liabilities

     9,558          9,819    

 

Deferred rent

     52          52    

 

Secured promissory note (including accrued interest), net of issuance costs

     5,049          6,550    
  

 

 

    

 

 

 

 

Total liabilities

     14,659          16,421    

 

Commitments and contingencies (note 7)

     

 

Stockholders’ equity:

     

 

Common stock, $0.0001 par value; 100,000,000 shares authorized as of March 31, 2017 and December 31, 2016; 39,190,619 and 16,815,997 shares issued and outstanding as of March 31, 2017 and December 31, 2016, respectively

     4          2    

 

Additional paid-in capital

     232,285          201,252    

 

Accumulated deficit

     (203,766)          (196,769)    
  

 

 

    

 

 

 

 

Stockholders’ equity

     28,523          4,485    
  

 

 

    

 

 

 

 

Total liabilities and stockholders’ equity

     $ 43,182          $ 20,906    
  

 

 

    

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

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ZOSANO PHARMA CORPORATION AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited; in thousands, except per share amounts)

 

           Three Months Ended March 31,        
     2017      2016  
     

Revenue

     $ -              $ -        

Operating expenses:

     

Research and development

     4,626            5,622        

General and administrative

     2,122            2,176        
  

 

 

    

 

 

 

Total operating expenses

     6,748            7,798        
  

 

 

    

 

 

 

Loss from operations

     (6,748)           (7,798)       

Other expense:

     

Interest expense, net

     (247)           (316)       

Other expense, net

     (2)           (1)       
  

 

 

    

 

 

 

Loss before provision for income taxes

     (6,997)           (8,115)       

Provision for income taxes

     -              -          
  

 

 

    

 

 

 

Net loss

     (6,997)           (8,115)       

Other comprehensive gain:

     

 

Unrealized gain on marketable securities, net of tax effect

     -              39        
  

 

 

    

 

 

 

Comprehensive loss

     $       (6,997)           $               (8,076)       
  

 

 

    

 

 

 

Net loss per common share – basic and diluted

     $ (0.34)           $ (0.68)       
  

 

 

    

 

 

 

Weighted-average shares used in computing net loss per common share – basic and diluted

     20,335            11,967        
  

 

 

    

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

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ZOSANO PHARMA CORPORATION AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited; in thousands)

 

           Three Months Ended March 31,        
     2017      2016  

Cash flows from operating activities:

     

Net loss

     $ (6,997)          $ (8,115)    

Adjustments to reconcile net loss to net cash used in operating activities:

 

     

Depreciation and amortization

     628           622     

Stock-based compensation

     233           312     

Amortization of debt discount/accretion of premium

     (6)          (8)    

Accrued interest

     30           112     

Deferred rent

     -             5     

Change in operating assets and liabilities:

     

Interest receivable

     -             28     

Prepaid expenses and other assets

     (489)          (1,219)    

Accounts payable

     (538)          195     

Accrued compensation and other accrued liabilities

     163           (272)    
  

 

 

    

 

 

 

Net cash used in operating activities

     (6,976)          (8,340)    
  

 

 

    

 

 

 
     

Cash flow from investing activities:

     

Purchase of property and equipment

     (77)          (204)    

Proceeds from maturities of investments in marketable securities

     -             8,460     

Decrease in other investment

     -             (2)    
  

 

 

    

 

 

 

Net cash provided by (used in) investing activities

     (77)          8,254     
  

 

 

    

 

 

 
     

Cash flow from financing activities:

     

Proceeds from public offering of securities, net of underwriting commissions, discounts and other offering costs

     26,623           -      

Proceeds from exercise of warrants and issuance of common stock

     4,041           -      

Payment of loan principal

     (1,410)          -      

Proceeds from exercise of stock options and issuance of common stock

     137           1     
  

 

 

    

 

 

 

Net cash provided by financing activities

     29,391           1     
  

 

 

    

 

 

 
     

Net increase (decrease) in cash and cash equivalents

     22,338           (85)    

Cash and cash equivalents at beginning of period

     15,003           6,646     
  

 

 

    

 

 

 

Cash and cash equivalents at end of period

     $     37,341           $       6,561     
  

 

 

    

 

 

 
     

Supplemental cash flow information:

     

Interest paid

     $ 231           $ 301     

Non-cash investing activities:

     

Acquisition of property and equipment under accounts payable

     $ 16           $ -      

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

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Zosano Pharma Corporation and Subsidiary

Notes to Condensed Consolidated Financial Statements

March 31, 2017

 

1. Organization

The Company

 Zosano Pharma Corporation (“the Company”) is a clinical stage pharmaceutical company focused on providing rapid symptom relief to patients using the Company’s proprietary intracutaneous delivery system to administer drugs through the skin. The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles primarily for treatment of central nervous system indications. Our intracutaneous technology offers rapid onset, consistent drug delivery, improved ease of use and room-temperature stability benefits that we believe would provide a potentially favorable alternative to using oral formulations or injections.

As of March 31, 2017, Zosano Pharma Corporation has one wholly owned subsidiary, ZP Opco, Inc. (“Opco”) through which the Company conducts its primary research and development activities.

 

2. Summary of Significant Accounting Policies

Basis of Presentation

The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information, the instructions to Form 10-Q and Regulation S-X. They do not include all the information and notes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three-month period ended March 31, 2017 are not necessarily indicative of the results that may be expected for the year ending December 31, 2017 or any other subsequent period. These financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2016 included in the Company’s annual report on Form 10-K filed with the Securities and Exchange Commission.

Use of Estimates

The preparation of the accompanying condensed consolidated financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the condensed consolidated financial statements, and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates.

Liquidity and Substantial Doubt in Going Concern

 The accompanying condensed consolidated financial statements have been prepared in conformity with U.S. GAAP, which contemplate continuation of the Company as a going concern. As of March 31, 2017, the Company has an accumulated deficit of $203.8 million, as well as recurring operating losses and negative cash flows from operating activities. Presently, the Company does not have sufficient cash resources to meet its plans in the next twelve months from issuance of these financial statements.

The Company has financed its operations primarily through the sale of equity securities, debt financing and payments received under its former licensing and collaboration agreements with pharmaceutical companies. To date, none of the Company’s product candidates have been approved by the Food and Drug Administration for sale. The Company will continue to require additional financing to develop its product candidates and fund operating losses. Management intends to seek capital to support the Company’s initiatives through equity or debt financing, collaboration or other arrangements with corporate partners, and/or other sources of financing. However, if such financing is not available at adequate levels or on acceptable terms, the Company could be required to significantly reduce its operating expenses and delay, reduce the scope of, or eliminate some of its development programs, out-license intellectual property rights, or a combination of the above, which may have a material adverse effect on the Company’s business, results of operations, financial condition and/or its ability to meet its scheduled obligations on a timely basis, if at all. Although management has been successful in raising capital in the past, most recently in March 2017, there can be no assurance that the Company will be successful, or that any needed financing will be available in the future at terms acceptable to the Company.

 

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These factors raise substantial doubt regarding the Company’s ability to continue as a going concern within one year after the issuance date of this filing. There are no assurances that such additional funding will be achieved and that the Company will succeed in its future operations. The Company’s inability to obtain required funding in the near future or its inability to obtain funding on favorable terms will have a material adverse effect on its operations and strategic development plan for future growth. If the Company cannot successfully raise additional capital and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected, and the Company may have to cease operations.

Consolidation

The condensed consolidated financial statements include the accounts of Zosano Pharma Corporation and Opco. Intercompany balances and transactions have been eliminated in consolidation.

Significant Accounting Policies

There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2017, as compared to the significant accounting policies described in Note 2 of the “Notes to Consolidated Financial Statements” in the Company’ s Annual Report on Form 10-K for the year ended December 31, 2016.

Research and Development Expenses

Research and development costs are charged to expense as incurred and consist of costs related to (i) furthering the Company’s research and development efforts, and (ii) designing and manufacturing the Company’s intracutaneous microneedle patch and applicator for the Company’s clinical and nonclinical studies.

Net Loss Per Common Share

Basic net income (loss) per common share is calculated by dividing the net income (loss) by the weighted- average number of common shares outstanding during the period, without consideration for potential dilutive common stock equivalents. Diluted net income (loss) per common share is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period. For purposes of this calculation, warrants and options to purchase common stock are considered potential dilutive common stock equivalents. For the three months ended March 31, 2017 and 2016, diluted net loss per common share was the same as basic net loss per common share since the effect of inclusion of potentially dilutive common stock equivalents would have an antidilutive effect due to the loss reported.

The following outstanding common stock equivalents were excluded from the computations of diluted net loss per common share for the periods presented as the effect of including such securities would be antidilutive:

 

     March 31,  
     2017     2016  
     (unaudited; in shares)  

Warrants to purchase common stock

     6,946,340         72,379    

Options to purchase common stock

     1,786,000     (1)       1,383,319    
  

 

 

   

 

 

 
                     8,732,340                         1,455,698    
  

 

 

   

 

 

 

(1) Total does not include 670,000 conditional stock options granted to certain executives since these grants are subject to approval by the Corporation’s shareholders of an amendment of the 2014 Plan.

 Recent Accounting Pronouncements

In February 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Updated (ASU) 2017-05, Other Income Gain and Losses from the Derecognition of Nonfinancial Assets . Under ASU 2017-05, all entities are required to derecognize or deconsolidate a business or nonprofit activity in accordance with Topic 810. The amendments in this update also simplifies Generally Accepted Accounting Principles (“GAAP”) by eliminating several accounting differences between transactions involving assets and transactions involving businesses. The amendments are effective for annual reporting periods after December 15, 2017, including interim periods within that reporting period. Early adoption is permitted, but only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that period. The Company is currently evaluating the impact of this accounting standard.

 

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In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows . This ASU provides guidance on the presentation of cash, cash equivalents and restricted cash in the statement of cash flows to reduce the current diversity in practice. The amendments in this update are effective for public business entities for fiscal year beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted. Adoption of this standard is not expected to have a material impact on the financial statements.

In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting . This Update is part of the FASB’s simplification initiative. The areas of simplification involve several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. The new standard is effective for annual periods beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted. The Company has adopted this standard for its fiscal year 2017. Adoption of this standard will not have a material impact on the financial statements.

In February 2016, the FASB issued ASU 2016-02, Leases . Under the new guidance, lessees will be required to recognize substantially all leases on the balance sheet as a right-of-use asset and recognize a corresponding lease liability. The accounting applied by a lessor is largely unchanged from that applied under previous U.S. GAAP. The new standard is effective for fiscal years, including interim periods within those fiscal years, beginning after December 15, 2018. The Company is currently evaluating the impact of this accounting standard.

In January 2016, the FASB issued ASU 2016-01, Financial Instruments – Overall: Recognition and Measurement of Financial Assets and Financial Liabilities , which amends the guidance in U.S. GAAP on the classification and measurement of financial instruments. Changes to the current guidance primarily affect the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. The guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company is currently evaluating the impact of this accounting standard.

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (“ASU2014-09”), which was subsequently modified in August 2015 by ASU No. 2015-14, Revenue from Contract with Customers: Deferral of the Effective Date . This guidance will be effective for fiscal years (and interim periods within those years) beginning after December 15, 2017. The core principle of ASU No. 2014-09 is that companies should recognize revenue when the transfer of promised goods or services to customers occurs in an amount that reflects what the company expects to receive. It requires additional disclosure to describe the nature, amount, timing and uncertainty of revenue and cash flows from contracts with customers. In 2016, the FASB issued additional ASUs that clarified the implementation guidance on principal versus agent considerations (ASU2016-08), on identifying performance obligations and licensing (ASU2016-10), and on narrow-scope improvements and practical expedients (ASU2016-12) as well as on the revenue recognition criteria and other technical corrections (ASU 2016-20). In our ongoing evaluation of the impact of these ASUs, the Company believes the adoption of these ASUs will not have a material impact on the financial statements.

 

3. Cash, Cash Equivalents and Investments

The following is a summary of the Company’s cash, cash equivalents, and marketable securities investments for each of the periods presented:

 

    March 31, 2017  
                Cost                     Gross Unrealized    
Gains
        Gross Unrealized    
Losses
            Fair Value          
    (unaudited; in thousands)  

Cash in bank

    $ 31,671          $ -          $ -         $ 31,671    

Money market funds

    5,670         -          -          5,670    

Certificates of deposit (restricted)

    35         -          -          35    
 

 

 

   

 

 

   

 

 

   

 

 

 
    $ 37,376         $ -          $ -          $ 37,376    
 

 

 

   

 

 

   

 

 

   

 

 

 

Classified as:

       

Cash and cash equivalents

          $ 37,341    

Restricted cash

          35    
       

 

 

 
          $ 37,376    
       

 

 

 

 

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    December 31, 2016  
                Cost                     Gross Unrealized    
Gains
        Gross Unrealized    
Losses
            Fair Value          
    (in thousands)  

Cash in bank

    $ 3,342         $       $ -         $ 3,342    

Money market funds

    11,661               -         11,661    

Certificates of deposit (restricted)

    35               -         35    
 

 

 

   

 

 

   

 

 

   

 

 

 
    $ 15,038         $       $ -         $ 15,038    
 

 

 

   

 

 

   

 

 

   

 

 

 

Classified as:

       

Cash and cash equivalents

          $ 15,003    

Restricted cash

          35    
       

 

 

 
          $ 15,038    
       

 

 

 

 

4. Fair Value of Financial Instruments

The Company records its financial assets and liabilities at fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:

 

    Level 1: Inputs which include quoted prices in active markets for identical assets and liabilities.
    Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
    Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The carrying values of certain assets and liabilities of the Company, such as cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities. The carrying value of the Company’s short-term notes payable approximates their fair value as the terms of the borrowing are consistent with current market rates and the duration to maturity is short. The carrying value of the Company’s long-term notes payable approximates fair value because the interest rates approximate market rates that the Company could obtain for debt with similar terms and maturities.

The following tables set forth the fair value of the Company’s financial instruments for each of the periods presented:

 

    March 31, 2017

 

 
   

 

      Level I      

 

          Level II      

 

          Level III      

 

          Total      

 

 
    (unaudited; in thousands)  

Financial Assets:

       

Money market funds

    $ 5,670           $ -             $ -               $ 5,670      
 

 

 

   

 

 

   

 

 

   

 

 

 

Total financial assets

    $ 5,670           $ -           $ -             $ 5,670      
 

 

 

   

 

 

   

 

 

   

 

 

 
    December 31, 2016

 

 
   

 

Level I

 

    Level II

 

    Level III

 

    Total

 

 
    (in thousands)  

Financial Assets:

       

Money market funds

    $     11,661           $ -             $ -               $ 11,661      
 

 

 

   

 

 

   

 

 

   

 

 

 

Total financial assets

    $ 11,661           $ -           $ -             $     11,661      
 

 

 

   

 

 

   

 

 

   

 

 

 

 

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5. Property and Equipment

The following summarizes the Company’s property and equipment for each of the periods presented (in thousands) :

 

            March 31, 2017               December 31, 2016    
        (unaudited)            

Laboratory and office equipment

    $       1,112          $     1,127    

Manufacturing equipment

      10,833            10,857    

Computer equipment and software

      314            314    

Leasehold improvements

      15,694            15,694    

Construction in progress

      2,023            1,961    
 

 

   

 

 
      29,976            29,953    

Less: accumulated depreciation

      (25,072)           (24,498)    
 

 

   

 

 
    $       4,904          $     5,455     
 

 

   

 

 

Depreciation and amortization expense was approximately $0.6 million for both the three months ended March 31, 2017 and 2016.

 

6. Debt Financing

In June 2014, the Company entered into a loan and security agreement with Hercules Capital, Inc. (“Hercules”) which provided the Company $4.0 million in debt financing. In June 2015, the Company entered into a first amendment to the loan and security agreement with Hercules to increase the aggregate principal amount of the loan to $15.0 million (“the Hercules Term Loan”). Upon the execution of the first amendment to the loan and security agreement, the Company used approximately $11.4 million of the Hercules Term Loan to prepay all amounts owing under the secured promissory note held by BMV Direct SOTRS LP, an affiliate of BioMed Realty Holdings, Inc. BMV Direct SOTRS LP owns more than 5% of our common stock and therefore is a beneficial owner of the Company.

The first amendment to the loan and security agreement with Hercules provides that the $15.0 million principal balance will be subject to a 12-month interest-only period beginning July 1, 2015, followed by equal monthly installment payments of principal and interest, with all outstanding amounts due and payable on December 1, 2018. The outstanding principal balance bears interest at a variable rate of the greater of (i) 7.95%, or (ii) 7.95% plus the prime rate as quoted in the Wall Street Journal minus 5.25%. The interest rate on the secured loan with Hercules was 7.95% as of March 31, 2017 and December 31, 2016. In addition, the Company will be obligated to pay a $100,000 legacy end of term charge on the earlier of June 1, 2017 or the date the Company prepays the Hercules Term Loan and a $351,135 end of term charge on the earlier of loan maturity or at the date the Company prepays the Hercules Term Loan. The Company may prepay all, but not less than all, of the Hercules Term Loan subject to a 0.5% prepayment charge of the then outstanding principal if prepaid on or after June 23, 2016 but prior to June 23, 2017, with no prepayment charge if prepaid thereafter. The Hercules Term Loan is secured by a first priority security interest and lien in and to all of the Company’s tangible and intangible properties and assets, including intellectual properties.

See Note 8 for a discussion of warrants to purchase common stock issued to Hercules in connection with the Hercules Term Loan.

 

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The following is a summary of the Company’s long-term debt, net of unamortized debt discount and issuance costs for the periods persented (in thousands) :

 

                                                                          
                 March 31, 2017                    December 31, 2016        
         (unaudited)         

Principal amount

           $ 10,712              $ 12,122    

Less:     unamortized debt issuance costs

     (32)          (41)    

  unamortized fair value of free standing warrant

     (57)          (75)    

Plus:     unamortized fair value debt premium

     109          143    

  accrued terminal interest

     350          310    

  accrued interest

     73          83    
    

 

 

    

 

 

 
Secured promissory note, net of unamortized debt issuance cost and premium            $ 11,155              $ 12,542    
    

 

 

    

 

 

 
Secured promissory note, current portion      6,106          5,992    
Secured promissory note, long-term portion      5,049          6,550    
    

 

 

    

 

 

 
Secured promissory note, net of unamortized debt issuance cost and premium and accrued interest            $             11,155              $             12,542    
    

 

 

    

 

 

 

Interest expense on the Company’s secured promissory note was $0.3 million for both the three months ended March 31, 2017 and 2016.

 

7. Commitments and Contingencies

The Company has an operating lease with BMR-34790 Ardentech Court LP, an affiliate of BMR Holdings, for its office, research and development, and manufacturing facilities in Fremont, California. In April 2012, the Company amended the lease agreement to reduce future rent obligations with a new lease term of seven years in exchange for a potential reduction of premises from a recapturable premises clause.

Rental expense under the related party operating leases was $0.2 million for both the three months ended March 31, 2017 and 2016.

As of March 31, 2017, future minimum payments under non-cancelable operating leases for each year ending December 31 are as follows:

 

        Total  
                (unaudited; in thousands)          

2017

  $     479    

2018

      650    

2019

      164    
   

 

 

 
  $     1,293    
   

 

 

 

 

8.  Stockholders’ Equity

On March 22, 2017, the Company closed on a registered public offering of 19,550,000 shares of common stock at a price of $1.50 per share, which included the exercise in full by the underwriters of their over-allotment option to purchase up to 2,550,000 additional shares of common stock. The total proceeds from the offering were $26.6 million, net of underwriter’s discounts and commissions and offering expenses.

 

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In August 2016, the Company completed a private investment in public equity transaction (“PIPE Financing”). The Company entered into a Securities Purchase Agreement with various purchasers, including members of the Company’s Board of Directors and executive management, pursuant to which the Company sold and issued shares of common stock and warrants to purchase shares of common stock for aggregate gross proceeds of $7.5 million. Costs related to the offering were $0.9 million. Pursuant to the Purchase Agreement, the Company sold 4,800,000 common shares at $1.32 per common share, the closing price per share on August 15, 2016, for gross proceeds of $6.3 million. Additionally, 9,600,000 warrants were sold, at a price of $0.125 per warrant, for gross proceeds of $1.2 million. Each warrant grants the holder the right to purchase one share of the Company’s common stock. The Company granted 4,800,000 Series A Warrants and 4,800,000 Series B Warrants. Series A Warrants and Series B Warrants have a per share exercise price of $1.45 and $1.55, respectively, and will expire one year and one week and five years, respectively, from the date of issuance, August 19, 2016. Certain of our directors and executive officers purchased an aggregate of 275,454 shares of common stock and an aggregate of 550,908 warrants in this offering at the same price as the other investors. In connection with the PIPE Financing, the Company filed a registration statement, Form S-3, with the U.S. Securities and Exchange Commission (“SEC”) registering for resale the shares of common stock and shares of common stock issuable upon exercise of the warrants. The registration statement was declared effective by the SEC on September 23, 2016.

The Company issued warrants to purchase common stock to Hercules in connection with the Hercules Term Loan entered into in June 2014 loan and security agreement and the June 2015 first amendment to the Hercules Term Loan. The warrants are exercisable, in whole or in part, any time before their expiration date as set forth below. See Note 6 for a discussion the Hercules Term Loan.

Below is a table summarizing the warrants issued and outstanding for each of the periods presented (unaudited):

 

    Warrants
Outstanding as of
  As of December 31,  
2016
    Warrants
        Exercised        

 

    Warrants
Outstanding
    As of March 31,    
2017
        Exercise    
Price

 

        Expiration    
Date

 

 

PIPE Financing - Series A

    4,800,000             1,844,214             2,955,786             $ 1.45         8/26/2017  

PIPE Financing - Series B

    4,800,000             881,825             3,918,175             $ 1.55         8/19/2021  

Hercules - June 2014

    31,674             -             31,674             $ 8.84         1/27/2020  

Hercules - June 2015

    40,705             -             40,705             $ 7.37         6/23/2020  
 

 

 

   

 

 

   

 

 

     

Total

    9,672,379             2,726,039             6,946,340            
 

 

 

   

 

 

   

 

 

     

As of March 31, 2017, the Company had 6,946,340 warrants outstanding classified as equity warrants. Each warrant grants the holder the right to purchase one share of our common stock. Equity warrants are recorded at their relative fair market value in the shareholders’ equity section of the balance sheet. The Company’s equity warrants can only be settled through the issuance of shares and does not have any anti-dilution or price resent provision. During the three months ended March 31, 2017, warrants were exercised to purchase 2,726,039 shares common stock for proceeds of $4.0 million.

 

9. Stock-Based Compensation

In connection with the Company’s Initial Public Offering (“IPO”) of its common stock in January 2015, the Company’s board of directors terminated the Company’s 2012 Stock Incentive Plan (“2012 Plan”) effective as of January 27, 2015 and no further awards may be issued under the 2012 Plan. However, the awards outstanding under the 2012 Plan at January 27, 2015 continue to be governed by the terms of the 2012 Plan. In July 2014, the board of directors and the stockholders of the Company adopted the 2014 Equity and Incentive Plan (“2014 Plan”), which became effective upon the closing of the IPO. As of March 31, 2017, options to purchase 1,329,232 shares of common stock were outstanding under the 2014 Plan with exercises prices ranging from $0.57 to $9.29 with a weighted average price of $1.95. Pursuant to the “evergreen” provision in the 2014 Plan, an additional 359,008 shares were automatically allocated for distribution under the 2014 Plan as of January 1, 2017.

On September 7, 2016, the Company awarded an inducement option grant to our Chief Business Officer to purchase 252,000 shares of our common stock at an exercise price of $0.77 per share. On January 19, 2017, the Company awarded an inducement option to a new employee to purchase 35,000 shares of our common stock at an exercise price of $1.14 per share. These inducement option grants were issued outside of the existing equity compensation plans in accordance with NASDAQ listing rule 5635(c)(4). The inducement grants have a term of 10 years and vest at the rate of 25% of the shares on the first anniversary of the commencement of such employee’s employment with the Company and monthly, thereafter, so that the option is fully vested on the fourth anniversary of the vesting start date.

On November 2, 2016, the Company granted a total of 670,000 conditional stock options at $0.57 per share to certain executive officers. The grants are subject to approval by the Corporation’s stockholders of an amendment to the 2014 Plan that would increase the number of shares available for issuance by an amount sufficient to cover the new grants.

 

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The following table summarizes option and award activity, excluding conditional grants and inducement grants, for the three months ended March 31, 2017 (unaudited):

 

    Shares
    Available    
for

Grant

 

      Outstanding  
Number

of Shares

 

    Weighted-
Average
Exercise

  Price per  
Share
    Weighted-
Average
Remaining
  Contractual  
Term

(In Years)

 

    Aggregate  
Intrinsic
Value

 

 

Balance at December 31, 2016

    55,815         1,594,058        $ 1.93       8.45    $ 18,900    

Additional shares reserved

    359,008         -        $ -        

Options granted

    (23,000)         23,000        $ 1.14        

Options exercised

    -         (98,583)        $ 1.40        

Options cancelled/forfeited

    19,475         (19,475)        $ 2.56        
 

 

 

   

 

 

       

Balance at March 31, 2017

    411,298         1,499,000        $ 1.94       8.84    $ 639,233    
 

 

 

   

 

 

       

Exercisable at March 31, 2017

      503,614        $ 2.34       8.15    $ 109,183    
   

 

 

     

 

 

 

 

 
Vested or expected to vest at March 31, 2017       1,433,268       $ 1.97       8.81     $ 587,971    
   

 

 

     

 

 

 

 

 

The aggregate intrinsic values of options outstanding and exercisable, vested and expected to vest were calculated as the difference between the exercise price of the options and the closing market value of the Company’s common stock as reported on NASDAQ as of March 31, 2017.

The following table summarizes the composition of stock options outstanding and exercisable under the 2012 Plan and the 2014 Plan and it excludes conditional grants and inducement grants, as of March 31, 2017 (unaudited):

 

    Options Outstanding     Options Exercisable  

  Exercise Price            

          Number of        
Shares
    Weighted-
Average
Remaining
Contractual
        Life (in years)         
            Weighted        
Average

Exercise
Price
            Number of        
Shares
            Weighted        
Average

Exercise
Price
 

  $0.57 - $0.57

    90,000           9.59           $ 0.57           29,998           $ 0.57      

  $0.85 - $0.85

    400,000           9.73           $ 0.85           -           $ -      

  $1.14 - $2.11

    180,780           6.95           $ 1.36           133,922           $ 1.39      

  $2.26 - $2.26

    328,394           8.71           $ 2.26           103,869           $ 2.26      

  $2.34 - $9.29

    499,826           8.78           $ 3.06           235,825           $ 3.14      

Stock-Based Compensation Expense

Total stock-based compensation expense recognized for grants under the approved option plans, conditional grants, and inducement grants, was as follows (unaudited):

 

        Three months ended March 31,      
   

 

2017

   

 

2016

 
    (in thousands)  

Research and development

          $ 61               $ 139    

General and administrative

    172         173    
 

 

 

   

 

 

 
          $ 233               $ 312    
 

 

 

   

 

 

 

As of March 31, 2017, the Company had $2.4 million of total unrecognized stock-based compensation, net of estimated forfeitures, related to outstanding stock options that will be recognized over a weighted-average period of 3.23 years.

The Company uses the Black-Scholes model for valuing its options and awards granted to employees and non-employees. The Black-Scholes option pricing model requires various highly judgmental assumptions including expected volatility and expected term. The expected volatility is based on the historical stock volatilities of several of the Company’s publicly listed peers as the Company does not have sufficient trading history to use the volatility of its own common stock. To estimate the expected term, the Company has opted to use the simplified method which is the use of the midpoint of the vesting term and the contractual term.

 

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The Company did not record stock-based compensation in connection with non-employee grants for the three months ended March 31, 2017. The following table illustrates the input assumptions used to value employee stock option grants for the three months ended March 31, 2017 and 2016 (unaudited):

 

                     For the three months ended  March 31,                
     2017   2016

Dividend yield

   0%   0%

Risk-free interest rate

   2.13%   1.97%

Expected volatility

   89%   89%

Expected term (years)

   6.08   6.08

Item 2.     Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the financial statements and accompanying notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, filed with the Securities and Exchange Commission, or SEC, on March 1, 2017. This discussion contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Such forward looking statements involve risks and uncertainties. We use words such as “may,” “continue,” “goal,” “would,” “could,” “might,” “project,” “anticipate,” “intend,” “forecast,” “designated,” “approximate,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “predict,” “potential,” “believe,” “should” or negatives of these words and similar expressions and references to future periods to identify forward-looking statements. Although we believe the expectations reflected in these forward-looking statements are reasonable, such statements are inherently subject to risk and we can give no assurances that our expectations will prove to be correct. These statements appearing throughout this Quarterly Report on Form 10-Q are statements regarding our intent, belief, or current expectations, primarily regarding our operations. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Quarterly Report on Form 10-Q. As a result of many factors, such as those set forth under “Risk Factors” under Item 1A of Part II below, and elsewhere in this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements. We undertake no obligation to update these forward-looking statements to reflect events or circumstances after the date of this report or to reflect actual outcomes.

Overview

Zosano Pharma and its subsidiary (“the Company”) is a clinical stage pharmaceutical company that has developed a proprietary intracutaneous delivery system. It can offer rapid absorption of drug while avoiding the gastrointestinal tract (“GI tract”), consistent drug delivery and room-temperature stability, benefits that we believe differentiate our delivery platform from other non-oral formulations or injections. By focusing our development efforts on the delivery of established molecules with known safety and efficacy and premium pricing, we plan to reduce our clinical and regulatory risk and development costs and accelerate our time to commercialize.

Our intracutaneous patch consists of an array of titanium microneedles that is coated with our proprietary formulation of a previously approved drug that is attached to an adhesive patch. When the patch is applied with our hand-held applicator, the microneedles penetrate the skin resulting in dissolution and absorption of the drug through the capillary bed. We believe our system enables rapid and consistent delivery of the drug that is easy and convenient to administer. We focus on developing our microneedle patch system for indications in which rapid onset, ease of use and stability offer significant therapeutic and practical advantages, for markets where there is a need for more effective therapies.

Our development efforts are focused on our product candidate, M207. M207 is our proprietary formulation of zolmitriptan coated onto our patented intracutaneous microneedle patch, which is then applied with our proprietary applicator to ensure uniform and consistent application. Zolmitriptan is one of a class of serotonin receptor agonists known as triptans and is used as an acute treatment for migraine. Migraine is a debilitating neurological disease, symptoms of which include moderate to severe headache pain, nausea and vomiting, and abnormal sensitivity to light and sound. The objective of M207 is to provide faster onset of efficacy and sustained freedom from migraine symptoms by delivering rapid absorption while avoiding GI tract. In July 2016, we announced the dosing of the first subject in the M207 pivotal efficacy trial, known as the ZOTRIP trial.

 

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In February 2017, we announced the completion and results of our ZOTRIP pivotal efficacy trial for M207. Our ZOTRIP trial was a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack. The ZOTRIP trial results demonstrated that the 3.8mg M207 dose achieved statistically significant pain freedom and most bothersome symptom freedom at two hours. While the 1.0mg and 1.9mg doses of M207 demonstrated statistical significance in pain freedom at two hours, they did not achieve statistical significance in freedom from most bothersome symptoms at two hours.

We have no product sales to date, and we will not have product sales unless and until we receive approval from the United States Food and Drug Administration (“FDA”) or equivalent foreign regulatory bodies, to market and sell our product candidate. Accordingly, our success depends not only on the development, but also on our ability to finance the development of the product. We will require substantial additional funding to complete development and seek regulatory approval for these products. Additionally, we currently have no sales, marketing or distribution capabilities and thus our ability to market our products in the future will depend in part on our ability to develop such capabilities either alone or with collaboration partners.

M207 Clinical Trial

We are planning to meet with the FDA to confirm the dose and design of the study in order to start the safety study later this year. We will require additional financing to complete this safety study. Consistent with FDA feedback, the safety study is designed to include a total of 250 subjects, who historically had experienced two to eight migraines per month, with the goals of 150 subjects completing at least six months dosing and 50 subjects completing 12 months of dosing. The safety study is planned to be an open-label study with investigator visits at months one, two, three, six, nine and twelve to record adverse events. The primary objective of the safety study is to measure adverse events and local tolerability during repeated administration. Other endpoints are electrocardiography, and laboratory parameters, as well as percentage of headaches with pain-free response.

While we are considering pursuing clinical development and regulatory approval of our M207 product candidate through commercialization, we remain open to opportunities with potential strategic partners to ensure our product candidate will receive the best chance of commercial success.

In March 2017, we closed an underwritten public offering pursuant to a registration statement on Form S-1 of 19,550,000 shares of our common stock sold at a price of $1.50 per share, including 2,550,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock. The proceeds from the offering were $29.3 million, and the net proceeds to us, after deducting underwriting discounts, commissions and reimbursable costs of approximately $2.2 million and offering expenses of approximately $0.5 million, were approximately $26.6 million.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The preparation of our financial statements in conformity with U.S. GAAP requires our management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. Our management believes judgment is involved in determining revenue recognition, the fair value-based measurement of stock-based compensation, accruals and warrant valuations. Our management evaluates estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the financial statements. If our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material adverse effect on our results of operations, liquidity and financial condition.

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (“the JOBS Act”). Emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards, and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

There have been no significant and material changes in our critical accounting policies and use of estimates during the three months ended March 31, 2017, as compared to those disclosed in “Part II, Item 7 – Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2016 filed with the SEC.

 

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Financial Operations Overview

As of March 31, 2017, we had an accumulated deficit of $ 203.8 million. We have incurred significant losses and expect to incur significant and increasing losses in the foreseeable future as we advance our product candidates into later stages of development and, if approved, commercialization.

We expect our research and development expenses related to clinical trials to increase significantly as we continue to advance our product candidates through clinical development. Because of the numerous risks and uncertainties associated with our technology and drug development, we are unable to predict the timing or amount of expenses incurred or when, or if, we will be able to achieve profitability.

Research and development expenses

Research and development expenses represent costs incurred to conduct research, such as the discovery and development of our proprietary product candidates. We recognize all research and development costs as they are incurred.

Research and development expenses consist of:

 

    production costs which include, but are not limited to, employee-related expenses, including salaries, benefits and stock-based compensation expense, and fees paid to conduct nonclinical studies, drug formulation, and cost of consumables used in nonclinical and clinical trials;

 

    expenses related to the purchase of active pharmaceutical ingredients and raw materials for the production of our intracutaneous microneedle patch system, including fees paid to contract manufacturing organizations or CMOs;

 

    fees paid to contract research organizations (“CROs”) clinical consultants, clinical trial sites and vendors, including institutional review boards (“IRBs”), in conjunction with implementing and monitoring our clinical trials and acquiring and evaluating clinical trial data, including all related fees, such as for investigator grants, patient screening fees, laboratory work and statistical compilation and analysis;

 

    fees paid to conduct clinical studies, drug formulation, and cost of consumables used in nonclinical and clinical trials;

 

    other consulting fees paid to third parties; and

 

    allocation of certain shared costs, such as facilities-related costs and information technology (“IT”) support services.

For the immediate future, our research and development efforts and resources will be focused primarily on advancing our product candidate M207 through clinical development. We are actively seeking opportunities to enter into collaborations with strategic partners to further the clinical and commercial development of our other product candidates, such as Daily B104, Weekly B206 and D107.

We cannot forecast with any degree of certainty if any of our product candidates will be subject to future collaborations or how such arrangements would affect our development plans or capital requirements. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.

General and administrative expenses

General and administrative expenses consist principally of personnel-related costs, professional fees for legal, consulting, audit and tax services, rent and other general operating expenses not otherwise included in research and development.

Other expenses

Interest expense, net. Interest expense, net of interest income, consists primarily of interest costs related to our debt and the amortization of debt discount and issuance costs. Interest expense for the three months ended March 31, 2017 and 2016 reflects accrued and paid interest related to the term loan with Hercules Capital, Inc., or Hercules, and the related amortization of debt discount and issuance costs.

 

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Other expense, net . Other income or expense consists of certain miscellaneous income or expenses that are not included in other categories of the condensed consolidated statements of operations. ( See detailed explanations under the subheading, Results of Operations ).

Results of Operations

Comparison of the three months ended March 31, 2017 and 2016

In connection with our decision to concentrate on the clinical development of M207, in March of 2016 we streamlined our organization and implemented a workforce reduction with the objective of reducing our expenses and reinvesting the savings from the workforce reduction in our M207 clinical development efforts.

Research and development expenses

 

           Three months ended March 31,              Change       
     2017      2016            Amount          %       
     (In thousands)                       

Research and development

     $4,626               $5,622               $ (996)              (18%)          

Research and development expenses decreased approximately $1.0 million, or 18%, for the three months ended March 31, 2017 as compared to the same period in 2016. The decrease was primarily driven by approximately $0.5 million decrease in compensation and benefits resulting from the workforce reduction program associated with our strategic realignment and approximately $0.5 million decrease in costs for the M207 efficacy study. These decreases were partially offset by an increase of approximately $0.1 million in preclinical projects costs.

General and administrative expenses

 

           Three months ended March 31,              Change  
     2017      2016              Amount            %  
     (In thousands)                  

General and administrative

     $     2,122          $ 2,176              $    (54)              (2%)      

General and administrative expenses decreased approximately $54,000, or 2%, for the three months ended March 31, 2017 as compared to the same period in 2016. General and administrative expenses were essentially unchanged over the comparable periods, and were primarily composed of personnel, legal, consulting costs and stock-based compensation expense.

Other expense, net

 

           Three months ended March 31,              Change     
     2017      2016              Amount            %   
     (In thousands)                   

Interest expense, net

     $        (247)          $      (316)            $  69          22%     

Other expense, net

     (2)          (1)            (1)          (100%)     

Interest expense, net decreased approximately $69,000, or 22%, for the three months ended March 31, 2017 as compared to the same period in 2016. Interest expense is primarily attributable to the Hercules Term Loan. The decrease in interest expense is attributable to the lower interest costs resulting from the lower loan principal balance during the three months ended March 31, 2017 as compared to the same period in 2016. Other expense, net was nearly unchanged for the three months ended March 31, 2017 as compared to the same period in 2016.

Liquidity and Capital Resources

Since our inception in October 2006, we have funded our operations primarily through a combination of equity offerings, secured and unsecured borrowings from private investors, bank credit facilities, and licensing and service revenue from our license and collaboration agreements. We have incurred recurring operating losses and negative cash flows from operating activities since inception, and as of March 31, 2017, had an accumulated deficit of $203.8 million. We expect to incur additional losses in the future to conduct research and development of our M207 product candidate and to conduct pre-commercialization manufacturing activities. As of March 31, 2017, we had approximately $37.3 million in cash and cash equivalents. Presently, we do not have sufficient cash resources to meet our plans in the next twelve months following the issuance of these financial statements.

 

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In accordance with ASU No. 2014-15 Presentation of Financial Statements – Going Concern (Subtopic 205-40), our management evaluates whether there are conditions or events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued.

We will continue to require additional financing to develop our product candidates and fund operating losses. Our plans to meet our operating cash flow requirements include financing activities such as private placements of our common stock, preferred stock offerings, issuances of debt and convertible debt instruments and collaborative or other arrangements with corporate sources. We anticipate that we will need to raise substantial additional capital, the requirements of which will depend on many factors, including, but not limited to:

 

    the scope, progress, expansion, costs, and results of our clinical trials;
    the scope, progress, expansion, and costs of manufacturing our product candidates;
    the timing of and costs involved in obtaining regulatory approvals;
    the type, number, costs, and results of the product candidate development programs which we are pursuing or may choose to pursue in the future;
    our ability to establish and maintain development partnering arrangements;
    the timing, receipt and amount of contingent, royalty, and other payments from any of our future development partners;
    the emergence of competing technologies and other adverse market developments;
    the costs of maintaining, expanding, and protecting our intellectual property portfolio, including potential litigation costs and liabilities;
    the resources we devote to marketing, and, if approved, commercializing our product candidates;
    our ability to draw funds from our loan and security agreement; and
    the costs associated with being a public company.

If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate our development programs and clinical trials. We may also be required to sell or license to others technologies or clinical product candidates or programs that we would prefer to develop and commercialize ourselves.

These factors raise substantial doubt regarding our ability to continue as a going concern within one year after the issuance date of this filing. There are no assurances that such additional funding will be achieved and that we will succeed in our future operations. Adequate additional funding may not be available to us on acceptable terms or at all. Our inability to obtain required funding in the near future or our inability to obtain funding on favorable terms will have a material adverse effect on our operations and strategic development plan for future growth. If we cannot successfully raise additional capital and implement our strategic development plan, our liquidity, financial condition and business prospects will be materially and adversely affected, and we may have to cease operations.

The following table shows a summary of our cash flows for the three months ended March 31, 2017 and 2016:

 

             Three Months Ended March 31,               
     2017        2016       
     (In thousands)       

Net cash (used in) provided by:

          

Operating activities

         $     (6,976)                $     (8,340)       

Investing activities

     (77)            8,254       

Financing activities

     29,391            1       
  

 

 

      

 

 

    

Net increase (decrease) in cash and cash equivalents

         $     22,338                $ (85)       
  

 

 

      

 

 

    

Operating Cash Flow : Net cash used in operating activities was approximately $7.0 million and $8.3 million for the three months ended March 31, 2017 and 2016, respectively. Net cash used during the first three months of 2017 was primarily due the closing costs of the M207 efficacy study and professional fees and administrative expenses incurred in the course of our continuing operations. Net cash used during the first three months of 2016 was primarily due to personnel costs related to the manufacturing of our M207 clinical trial materials, preclinical studies costs, certain termination benefits paid to a former executive, costs associated with our workforce reduction in March 2016, professional fees and administrative expenses incurred in the course of our continuing operations.

Investing Cash Flow : Net cash used in investing activities during the first three months of 2017 was approximately $77,000 as compared to net cash provided by investing activities of $8.3 million in the same period of 2016. Net cash used in investing activities during the first three months of 2017 was due to purchases of property, plant, and equipment. Net cash provided by investing activities during the first three months of 2016 was primarily the result of the maturity of certain marketable securities in our investment portfolio.

 

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Financing Cash Flow : Net cash provided by financing activities was approximately $29.4 million and $1,000 for the three months ended March 31, 2017 and 2016, respectively. Net cash generated by financing activities for the first three months of 2017 was primarily due to proceeds from a registered public offering of $26.6 million, net of underwriter’s discounts, commissions, and offering expenses and to warrant exercises to purchase 2,726,039 shares common stock for proceeds of $4.0 million. Net cash generated by financing activities during first three months of 2016 was due to proceeds from stock option exercise. These increases were partially offset by payments on the Hercules Term Loan of approximately $1.4 million for the first three months of 2017.

Contractual Obligations and Commitments

Our primary contractual obligations as of March 31, 2017 consist of operating leases of approximately $1.3 million and long-term debt obligations of approximately $12.0 million (including end of term payments and periodic interest payments). Operating leases represent our future minimum rental commitments under our operating leases. Long-term debt obligations include our secured term loan facility with Hercules Capital, Inc. (“Hercules”).

Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Cash balances are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to regulatory limits. Therefore, the Company is exposed to credit risk when the Company’s cash balances exceed FDIC insurance limits.

Recent Accounting Pronouncements

See Note 2 to the accompanying condensed consolidated financial statements for the Recent Accounting Pronouncements.

Off-Balance Sheet Arrangements

We currently have no off-balance sheet arrangements, such as structured finance, special purpose entities or variable interest entities.

Item 3.    Quantitative and Qualitative Disclosures About Market Risk

We are exposed to market risks in the ordinary course of our business. We had cash and cash equivalents of $37.3 million as of March 31, 2017, which consisted of bank deposits and money market funds. The cash and cash equivalents are held for working capital purposes and such interest-earning instruments carry a degree of interest rate risk. Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash and cash equivalent balances exceed the maximum amounts insured by the FDIC.

The interest rate on our outstanding term loan is variable. To date, fluctuations in interest income and expense have not been significant. However, fluctuations in market interest rates in the future could have a material impact on our financial condition and results of operations.

Item 4.    Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Interim Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2017. The term “disclosure controls and procedures,” as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms.

Based on the evaluation of our disclosure controls and procedures as of March 31, 2017, our Interim Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures are designed to, and are effective to, provide assurance at a reasonable level that the information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our Interim Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.

 

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Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Changes in Internal Control over Financial Reporting

There were no changes in our internal controls over financial reporting during the quarter ended March 31, 2017 identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II.    OTHER INFORMATION

Item 1.         Legal Proceedings

We are not party to any material pending legal proceedings. However, we may from time to time become involved in litigation relating to claims arising in the ordinary course of our business.

Item 1A.       Risk Factors

Investing in our common stock involves a high degree of risk. Our Annual Report on Form 10-K for the year ended December 31, 2016 includes a detailed discussion of our risk factors under the heading “Part I, Item 1A—Risk Factors.” There have been no material changes from such risk factors during the three months ended March 31, 2017. You should consider carefully the risk factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2016 and all other information contained in or incorporated by reference in this Quarterly Report on Form 10-Q before making an investment decision. If any of the risks discussed in the Annual Report on Form 10-K actually occur, they may materially harm our business, financial condition, operating results, cash flows or growth prospects. As a result, the market price of our common stock could decline, and you could lose all or part of your investment. Additional risks and uncertainties that are not yet identified or that we think are immaterial may also materially harm our business, financial condition, operating results, cash flows or growth prospects and could result in a complete loss of your investment.

Item 2.         Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3.         Defaults Upon Senior Securities

None.

Item 4.         Mine Safety Disclosures

Not Applicable.

Item 5.         Other Information

As previously announced on our Form 8-K filed with the SEC on April 10, 2017, we will hold our 2017 Annual Meeting of Stockholders (“the 2017 Annual Meeting”) on Wednesday, May 31, 2017, at 8:30 a.m., Pacific time. The record date for determining stockholders entitled to notice of, and to vote at, the 2017 Annual Meeting was April 26, 2017.

Because the 2017 Annual Meeting will be held more than 30 days before the anniversary of the 2016 annual meeting of stockholders, any stockholder proposal or director nomination for consideration at our 2017 Annual Meeting had to be submitted to the Secretary of the Company no later than 5:00 p.m., Pacific time, on April 20, 2017. Any such stockholder proposal or director nomination had to comply with our Bylaws as well as the requirements of Rule 14a-8 under the Securities Exchange Act of 1934, as amended (including the rules and regulations thereunder). We did not receive any stockholder proposals or director nominations for the 2017 Annual Meeting.

Item 6.         Exhibits

A list of exhibits is set forth on the Exhibit Index immediately following the signature page of this Quarterly Report on Form 10-Q, and is incorporated herein by reference.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Dated:      May 9, 2017  

  Zosano Pharma Corporation

 (Registrant)

 
 

/s/ John Walker

 
  John Walker  
  Interim Chief Executive Officer  
 

/s/ Georgia Erbez

 
  Georgia Erbez  
 

Chief Financial Officer and

Chief Business Officer

 

 

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EXHIBIT INDEX

 

  Exhibit 

 number 

   Description
31.1  

Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2  

Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1*  

Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101.INS  

XBRL Instance Document XBRL

101.SCH  

XBRL Taxonomy Extension Schema Document

101.CAL  

XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF  

XBRL Taxonomy Extension Definition Linkbase Document

101.LAB  

XBRL Taxonomy Extension Label Linkbase Document

101.PRE  

XBRL Taxonomy Extension Presentation Linkbase Document

 

   Filed herewith
  * Exhibit 32.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise specifically stated in such filing.

Exhibit 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO EXCHANGE ACT RULE 13a-14(a) AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, John Walker, certify that:

1.   I have reviewed this Quarterly Report on Form 10-Q of Zosano Pharma Corporation;

2.   Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.   Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.   The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)   Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)   Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)   Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)   Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.   The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)   All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)   Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

Date: May 9, 2017   By:   

 /s/ John Walker

     John Walker
     Interim Chief Executive Officer
     (Principal Executive Officer)

Exhibit 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO EXCHANGE ACT RULE 13a-14(a) AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Georgia Erbez, certify that:

1.   I have reviewed this Quarterly Report on Form 10-Q of Zosano Pharma Corporation;

2.   Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.   Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.   The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)   Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)   Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)   Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)   Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.   The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)   All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)   Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 9, 2017   By:   

/s/ Georgia Erbez

    Georgia Erbez
   

Chief Financial Officer and

Chief Business Officer

    (Principal Financial Officer)

Exhibit 32.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, John Walker, the Interim Chief Executive Officer of Zosano Pharma Corporation (the “Company”), and Georgia Erbez, the Chief Financial Officer and Chief Business Officer of the Company, hereby certify that, to their knowledge:

1.   The Quarterly Report on Form 10-Q for the period ended March 31, 2017 of the Company (the “Report”) fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934; and

2.   The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: May 9, 2017   By:   

/s/ John Walker

    John Walker
    Interim Chief Executive Officer
    (Principal Executive Officer)
Date: May 9, 2017   By:   

/s/ Georgia Erbez

    Georgia Erbez
   

Chief Financial Officer and

Chief Business Officer

    (Principal Financial Officer)